About the Department
The East Coast Hub is the next stage of our Global Development ambitions within the US. Within the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ campuses through both direct leadership of the core Clinical Operations function, as well as ensuring close collaboration with other areas of Global Development and US Clinical, Medical and Regulatory (CMR). Your skills, dedication and ambition will help us change lives for the better. In exchange, we’ll offer you an opportunity to work with extraordinary talent, continuously learn and develop, and drive change to defeat serious chronic conditions. We are changing lives, are you ready to make a difference?
The Position
This leadership position is accountable for resourcing, development, training and management of a highly performing Clinical Operations team. The position will provide strategic direction for, and executive oversight of, Clinical Operations matters relating to the project portfolio anchored within the East Coast Hub, including trial planning, study / protocol design and development, execution within budget and timelines, quality and compliance.
Relationships
This position reports to the Corporate Vice President (CVP) of Clinical Operations for CKAD and Rare Disease.
Essential Functions
Provide strategic and operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programsManaging the overall Clinical Operations strategy, direction and people development, by actively driving innovation and taking a broader and joint responsibility for clinical drug development across projectsEstablish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicatorsIn collaboration with other Vice Presidents of Clinical Operations in other global locations and therapy areas, proactively leads the optimisation of processes and drives the architecture and future operating model for Clinical OperationsIs accountable for driving an engaging culture in accordance with Novo Nordisk Way and for inspiring and motivating employees and teams through empowerment and by enabling judgement-based decision and agilityIs responsible for assuring compliance with the Novo Nordisk Quality system for Clinical Operations deliverablesProvide continuous assessment and alignment of the Clinical Operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution; accountable for maintaining pro-active approach to inspection readinessIs overall responsible for the Clinical Operations LoB budgetIs overall accountable for ensuring optimal resource utilization within the area/development portfolio at all timesIs responsible for providing feedback regarding resource constraints and progress on defined deliverables to relevant stakeholdersDrive talent and succession management, identifying high potentials and creates an environment where a learning culture is in focus to support individual and organizational learnings and developmentContribute actively to the Organisational Development Plan (ODP)Is a member of the CVP CKAD and Rare Disease Clinical Operations Leadership Team – including actively contributing to the leadership and future development of the areaOversee and trouble-shoot clinical development program challenges, processes, activities and risk mitigation strategies pertaining to the conduct of clinical trials and key milestone deliverables, with direct reports/functional leadsOversee and provide relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budgetSenior contributor for business development activities providing clinical expertise and strategic operational considerationsClinical representative of executive teams including, the Quality Counsel, Executive Safety Committee, GxP Risk Management Team, applicable CRO/vendor governance and due diligence teamsIs a member of the Head Quarter Trial Management Council (HQTM Council)Is sponsor/Steering Committee (StC) member of Global Trial Portfolio (GTP) improvement projects and initiatives as applicableSupports and enables knowledge sharing and capability building across teams, projects and skill areasDrives innovation in clinical drug development, not only within own area but taking a broad and joint responsibility across projects, e.g., via working groups, cross-project collaboration and HQTM Council initiativesLead by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goalsCommunicate regularly and effectively with senior leaders across the R&D organizationPerform other duties as required and assigned by supervisor
Physical Requirements
Approximately 30% overnight domestic and/or international travel, as needed. Ability to lift 0 - 10 lbs.
Development of People
Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
Bachelors, Masters or Doctorate degree in a life-sciences discipline with 15+ years progressive experience in clinical drug/device development working in a project oriented international matrix organization, including 5+ years of Clinical Operations line management experienceDomestic and international clinical trial execution experience requiredPost-approval clinical management experience a plusDirect management experience over clinically related functions and experience working in a matrix environment with other functional groups (eg. Regulatory, Medical Writing, Med Affairs, Commercial)In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesExperience in complex, rare and/or pediatric diseases, preferredAbility to manage early phase clinical programs up through to regulatory filingDemonstrated track record of successfully developing and executing on clinical development plansProven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activitiesProficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve functional area and/or organization goalsAnalytical thinker with excellent problem-solving skillsExcellent verbal and written communication skillsExcellent planning, organization, and project management skillsFlexibility to travel domestically and internationally, as requiredProficiency with Excel and Microsoft ProjectEnglish is the predominant language for most regulatory documents handled by this position; should be able to demonstrate good verbal and written English
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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